1. Field of the Invention
The invention relates to a device and related process for the collection of tissue and fluid specimens from bodily cavities, for example, the human uterus.
2. Description of the Prior Art
Aspirating curettes have been used to remove fluids and/or tissue from bodily cavities. Typically such apparatus has included a curette with a tissue scraping element at its distal end. The distal end of the curette also includes one or more specimen receiving openings leading to a passageway running axially therein. The passageway is commonly connected to a housing containing an outlet for connection to a vacuum source such as a syringe. A screen or other tissue collecting element is placed within the curette passageway or housing. The screen is removably positioned to permit easier examination of the specimen that collects on such screen.
Tissue and/or fluid collection apparatus as described have been heretofore manufactured in a variety of ways. U.S. Pat. No. 3,889,657 to Baumgarten discloses what is referred to as a uterine aspirating curette having a removable, tapered or conical specimen collection basket. Tissue is collected on the inside of the basket, but it is difficult to see and remove for examination. The uterine aspirating curette has a substantially blunt tip and provides four openings to a passageway running axially through the curette. The device is not designed to be used for anaerobic collection of tissue and fluid specimens. In addition, contamination of the device during insertion into the bodily cavity may occur, causing the specimens collected to be similarly contaminated.
U.S. Pat. No. 4,230,123 to Hawkins, Jr. discloses a needle sheath complex having a probe cannula with a stylus slidably mounted therein, such that the stylus substantially fills the probe cannula. The stylus projects from the end of the probe cannula such that a sharp end of the stylus is exposed. Upon location of a target, the stylus is removed from the probe cannula and a syringe is attached to draw a sample of fluid. The device does not have shields or covers for preventing contamination of the sample. Also, the collection process is very tedious and time consuming, and is not designed to be used for the anaerobic collection of tissue and fluid samples.
U.S. Pat. No. 4,311,140 to Bridgman discloses a vacuum curette having an improved curetting opening. The distal portion of the curette has at least a pair of tip openings opposed to one another. One of these openings has a semi-circular cross section, while the other has a rectangular cross section and is designed to macerate tissue for collection.
U.S. Pat. No. 4,338,952 to Augros discloses a device for taking samples of endometrium comprising a rod, a tube and at least one scraper element fixed at the end of the rod. The scraper element is designed to be retracted within the tube. Tissue collection occurs on the scraper element and the sample is then removed for examination. The device does not use a vacuum for the collection of tissue samples and cannot be used for fluid collection. Also, the device is unable to anaerobically collect tissue samples.
U.S. Pat. No. 4,393,879 to Milgrom discloses a tissue collecting apparatus comprising a curette having a tissue scraping element at its distal end. A proximal end of the curette is attached to a housing having an outlet adapted to be connected to a source of vacuum. Within the housing is an obliquely mounted tissue collecting screen. The use of such a tissue collecting screen is not conducive to anaerobic tissue and fluid sampling. Also, the specimen may become contaminated due to the lack of any contamination preventing shield or cover.
U.S. Pat. No. 4,396,022 to Marx discloses an endometrial tissue sampling apparatus comprising a sheath with a path dilating pilot obturator adapted to slide therein. Following insertion, the obturator is removed from the sheath and a syringe is attached to the outer end of the sheath. The syringe is then used to form a vacuum to draw the endometrium against the cutting edge of a scraping tip held on the sheath to remove tissue specimens which pass through the sheath into the syringe. The use of the syringe as a specimen collecting device does not permit discovery of anaerobic pathogens, as the specimen must be expelled into a container for examination, thus exposing it to air. Such exposure to air is toxic to strict anaerobes.
The prior art lacks the capability of effectively collecting anaerobic tissue and fluid samples.
Uterine infections are usually mixed, including organisms from the groups of aerobic, anaerobic, and facultatively anaerobic organisms. Aerobic organisms utilize oxygen for growth; lack of oxygen may result in cessation of growth, but not death. Facultative anaerobes can grow in the presence or absence of oxygen. Strict anaerobes, however, cannot tolerate any exposure to oxygen, which is fatally toxic to them. Therefore, the usual sampling devices will fail to collect viable anaerobes. Since successful selection of proper therapeutic agents requires culture and identification of all of the pathogenic organisms, failure of treatment may occur, with resulting prolonged morbidity, mortality or sterility.
In the case of postpartum infection, the baby may also have acquired the infection before or during birth. Diagnosis of the mother's infection provides indication of proper therapy for the baby and the diagnosis may be made more rapidly because of the larger inoculum of the maternal sample. Particularly in the case of Chlamydia trachomatis, which infects the baby's cornea and lungs, causing blindness and pneumonia, respectively, identification of pathogens in the maternal sample is as desirable as direct sampling of the baby.
Chlamydia trachomatis is an increasingly common cause of pelvic inflammatory disease (PID). It is an unusual bacterial pathogen in that it grows within the cell and is shed into the surrounding fluids. It can be found in extracellular fluid and as an intracellular organism. Since it is a fastidious intracellular parasite, it may be diagnosed either by culture or by cytologic examination of the tissue sample as well as the fluid from the syringe. The extracellular organisms are often present and may even be dead. Taking of a tissue sample, with the organisms inside the cells, can assure the pathologist of the correct identification of this pathogen. Once diagnosed, the pathogen can be treated with specific antibiotics. Broad spectrum antibiotics commonly used for treating pelvic infections may be ineffective against Chlamydia.
Another difficulty attendant with prior art aspirating curettes is the lack of a structure to effectively prevent contamination. Specimen contamination may occur when the device is introduced to the bodily cavity. Thus, a tissue and/or fluid specimen may contain samples from unwanted or unaffected areas. An additional disadvantage in many prior devices is the use of expensive tissue collecting screens.